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Topics for discussion related to use of investigational devices in human subjects research include:

How the IRB makes device determinations: When is a device an investigational device?
Exempt vs. non-significant risk (NSR) vs. significant risk (SR) devices
Information required in the protocol
PI and sponsor responsibilities for various categories of devices uses (e.g., applicable FDA regulations for SR vs. NSR)

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Topics for discussion related to use of investigational devices in human subjects research include:

How the IRB makes device determinations: When is a device an investigational device?
Exempt vs. non-significant risk (NSR) vs. significant risk (SR) devices
Information required in the protocol
PI and sponsor responsibilities for various categories of devices uses (e.g., applicable FDA regulations for SR vs. NSR)

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Topics for discussion related to use of investigational devices in human subjects research include:

How the IRB makes device determinations: When is a device an investigational device?
Exempt vs. non-significant risk (NSR) vs. significant risk (SR) devices
Information required in the protocol
PI and sponsor responsibilities for various categories of devices uses (e.g., applicable FDA regulations for SR vs. NSR)

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